Modular gastrointestinal prostheses

ABSTRACT

A modular system for therapy within a gastrointestinal system. The system includes anchoring or attachment functionality embodied in a low-profile implant technology and removable therapy components, which can be reversibly attached to these low-profile implants to accomplish various therapies. This modular design allows the physician to tailor the therapy to the patient&#39;s needs. The modular system has the potential to create conduits for diversion and/or restriction of food and organ secretions and to facilitate the treatment of metabolic disorders such as obesity and T2DM.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of U.S. application Ser. No. 12/752,697,filed Apr. 1, 2010, entitled “Modular Gastrointestinal Prostheses”,which claims the benefit under 35 U.S.C. §119 of U.S. ProvisionalApplication 61/211,853, filed on Apr. 3, 2009, entitled “Modular Systemsfor Intra-Luminal Therapies within Hollow Body Organs,” which areincorporated herein by reference in their entirety for all purposes.

TECHNICAL FIELD

This invention relates to prosthetic implants placed within thegastrointestinal system, including the stomach, the esophagus and theintestines. In particular, it relates to implant systems havingcomponents implantable and removable using endoscopic techniques, fortreatment of obesity, diabetes, reflux, and other gastrointestinalconditions.

BACKGROUND

Bariatric surgery procedures such as sleeve gastrectomy, the Rouen-Ygastric bypass (RYGB) and the bileo-pancreatic diversion (BPD) aresurgical procedures to modify food intake and/or absorption within thegastrointestinal system to effect weight loss in obese patients. Theseprocedures affect metabolic processes within the gastrointestinalsystem, by either short-circuiting certain natural pathways or creatingdifferent interaction between the consumed food, the digestive tract,its secretions and the neurohormonal system regulating food intake andmetabolism. In the last few years there has been a growing clinicalconsensus, that obese diabetic patients who undergo bariatric surgerysee a remarkable resolution of their Type-2 Diabetes Mellitus (T2DM)soon after the procedure. The remarkable resolution of diabetes afterRYGB and BPD typically occurs too fast to be accounted for by weightloss alone, suggesting that there may be a direct impact on glucosehomeostasis. The mechanism of this resolution of T2DM is not wellunderstood, and it is quite likely that multiple mechanisms areinvolved.

One of the drawbacks of bariatric surgical procedures is that theyrequire fairly invasive surgery, with potentially serious complicationsand long patient recovery periods. In recent years, there is anincreasing amount of ongoing effort to develop minimally invasiveprocedures to mimic the effects of bariatric surgery using minimallyinvasive procedures. One such procedure involves the use ofgastrointestinal implants that modify transport and absorption of foodand organ secretions. For example, U.S. Pat. No. 7,476,256 describes animplant having a tubular sleeve with an anchor having barbs. While theseimplants may be delivered endoscopically, the implants offer thephysician limited flexibility and are not readily removable orreplaceable, as the entire implant is subject to tissue in-growth afterimplantation. Moreover, stents with active fixation means, such as barbsthat penetrate in to the surrounding tissue, may potentially causetissue necrosis and erosion of the implants through the tissue, whichcan lead to serious complications such as systemic infection.

SUMMARY

According to various embodiments, the present invention is a modularintra-luminal implant systems for treating metabolic disorders such asobesity and diabetes, which provides far more flexible therapyalternatives than single devices to treat these disorders. These implantsystems include components that can be selectively added or removed tomimic a variety of bariatric surgical procedures with a single basicconstruct. The fundamental building blocks of the system includeanchoring implants that are placed within the GI system or someinstances around particular organs. These low-profile implants aredesigned for long-term performance with minimal interference with normalphysiological processes. Features of these anchoring implants allow themto act as docking stations for therapy implants designed for achievingcertain metabolic modification goals. By using a combination ofanchoring implants with corresponding replaceable tubular elements thatdock with them, it is possible to design therapies with particularmetabolic modification goals or those that mimic currently practicedbariatric surgical procedures. This allows the physician to customizethe therapy to the patient at the time of the initial procedure but alsoallows the flexibility to alter the therapy during the life-time of thepatient by replacing individual components.

According to some embodiments, the modular systems of the inventionincludes a anchoring implant portion (docking element) including anexpandable structure (e.g., a low profile stent or ring orfabric/elastomeric cuff) anchored within the esophagus, thegastro-esophageal junction, the pyloric junction, the duodenum or thejejunum and may have sleeve or graft extensions. The stents may beballoon expandable or self-expanding and anchor against the tissue withradial force. The rings could be made of self-expanding Nitinol andanchor to the tissue by entrapment of the tissue within the ringelements or by radial force. The cuffs could be either sutured orstapled or permanently or reversibly attached by other mechanical meansto the tissue. The anchoring implant includes or is adapted to receive(e.g., endoscopically) features that enable docking functionality. Thedocking functionality of the stent, ring or cuff, for example, couldtake the form of magnetic elements, hooks, mating mechanical elements orstructures (such as the stent braid or mesh) that are integral to theframework of the stent, ring or cuff or the sleeve or graft extension.The system also could be such that the docking functionality is notintegral to the stent, ring or cuff but is introduced later by attachingother elements such as magnets, hooks, mating mechanical elements etc tothe framework of the stent, ring, cuff or to the sleeve/graft extensionof the above implants. Therapeutic implants, such as tubular sleeves orstent grafts are adapted to be reversibly attached to the anchoringimplants. These therapeutic implants will have corresponding features(e.g., magnets, hooks, mechanical elements) to enable docking to theanchoring implants, so that the therapeutic implants can be reversiblyattached to the anchoring implants. In some embodiments, the tubularimplants will not be in contact with tissue to minimize or preventtissue in-growth and facilitate easy removal with endoscopicinstrumentation after long-term implantation.

According to various embodiments, the anchoring or docking implantscomprise stents or covered stents (stent grafts) that promote tissuein-growth without penetrating into the tissue. Such stents may include,for example, a self-expanding laser cut stent with non-penetratingstruts that engage the wall of the GI tract or a self-expanding stentbraided with a Dacron type fabric covering of the right porosity wouldpromote tissue in-growth and aid fixation.

According to various embodiments, the anchoring or docking implantscomprise a double braided stent (e.g., having a spacing between thebraids of 0.5 to 5.0 mm). This embodiment is optimized such that theouter braid could be securely anchored within tissue, but the tissuewould not grow into the inner braid, which can then be used to anchorthe replaceable implant.

According to various embodiments, the anchoring or docking implants arespecifically designed to be constrained at certain anatomic locations.Such designs, for example, may include a double-flange shaped ordumbbell-shaped implants placed at the pyloric junction or barrel shapedstents placed within the duodenal bulb.

According to various embodiments, the replaceable therapeutic implantsthat dock to the anchoring implants take the form of long tubes that canselectively channel the flow of food and secretions from organs (e.g.,the stomach, gall bladder, intestines and pancreas) to variousdestinations within the digestive tract. This diversion and bypass offood and organ secretions (e.g., insulin and incretin from the pancreasand bile from the gall bladder) could then be controlled by adjustingthe design features of the system where the implants are placed withinthe GI tract. The implants could also include restrictive stoma typeelements or anti-reflux valves. To divert food and secretions from thefirst part of the intestine, for example, an anchoring implant can beplaced within the duodenal bulb or at the pyloric junction. Then, a thintube about 1-2 feet in length with a funnel shaped proximal end and arigid ring shaped distal end can be introduced into the proximalduodenum and docked to the permanent implant. It would be possible tolater remove this by endoscopic means by simple undocking it from theanchoring implant. To restrict passage of food, a restrictive elementsuch as one created by a tapered stepped tube or a stent or a stentgraft can become the docking element and be reversibly attached to thedocking station.

According to various embodiments, the docking means may includeengaging/disengaging mechanical shape memory and super-elastic elements,attractive/repulsive and levitating magnetic mechanisms, loop-hoopfastener technologies etc.. The systems may be deployed with functionaldocking components or those components would be attached to thepermanent implants under endoscopic visual guidance. The docking meansis designed so that the therapeutic implants can be easily deployed andsecurely affixed to the anchoring implants. According to variousembodiment, the engaging elements of the docking system are arranged sothat they do not impinge on the surrounding tissue, nor would be latercovered with tissue layers. This facilitates disengaging the tubularsleeve elements from the stent with simple magnetic instruments orgrasper type endoscopic instruments or funnel shaped retrieval basketcatheters or using a draw-string type mechanism.

According to some embodiments, the anchoring element is integrated witha therapy component.

According to various embodiments, the present invention is a method oftreating gastro-esophageal reflux disease (GERD) including placing alow-profile implant within the stomach, the esophagus, the intestine orat internal junctions of these organs or around these organs, andsecurely attaching to the implant other gastro-intestinal implants thatpermit bypass of food and organ secretions from one site within thegastro-intestinal tract to other sites within the gastro-intestinaltract.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross sectional view of a portion of the digestive tract inthe body. A docking element is implanted in the duodenal bulb and atubular implant (sleeve) is attached to the docking element and extendedinto the duodenum to the ligament of treitz.

FIG. 2 is a cross sectional view of a portion of the digestive tract inthe body. An endoscope is inserted into the mouth, passing through theesophagus in to the stomach and the end of the scope is pointed to allowviewing of the pylorus.

FIG. 3 is a drawing of a typical endoscope used for diagnostic andtherapeutic procedures in the gastro intestinal (GI) tract.

FIG. 4A is a drawing of an over the wire sizing balloon that can be usedto measure the diameter of the pylorus, duodenal bulb, esophagus,pyloric antrum or other lumen in the GI tract.

FIG. 4B is a drawing of a monorail sizing balloon that can be used tomeasure the diameter of the pylorus, duodenal bulb, esophagus, pyloricantrum or other lumen in the GI tract.

FIG. 5 is a sectional view of a portion of the digestive tract in thebody. An endoscope is inserted into the GI tract up to the pylorus. Asizing balloon is inserted through the working channel and into the areaof the duodenal bulb. The balloon is inflated to measure the diameter ofthe duodenal bulb.

FIG. 6A is a drawing of a stent that can used as a docking element.

FIG. 6B is a drawing of a stent that can used as a docking element thathas a polymer covering on the inside and outside.

FIG. 7 is a tubular implant that can be used to bypass the stomach,duodenum or other intestinal lumen.

FIG. 8 is a drawing of a delivery catheter for the docking element andtubular implant.

FIG. 9A is a cross sectional view of a portion of the digestive tract inthe body. A delivery catheter with a docking element and tubular implantloaded onto the catheter are loaded onto an endoscope. The endoscope isthen advanced through the esophagus, stomach and into the duodenal bulb.

FIG. 9B is a cross sectional view of a portion of the digestive tract inthe body. A delivery catheter with a docking element and tubular implantloaded onto are loaded onto an endoscope. The endoscope is then advancedthrough the esophagus, stomach and into the duodenal bulb. The outersheath of the delivery catheter is refracted to partially deploy thedocking element into the duodenal bulb.

FIG. 10 is a drawing showing the docking element fully deployed into theduodenal bulb. The delivery catheter and endoscope has been has beenremoved to show clarity

FIG. 11 is a drawing showing the endoscope and delivery catheteradvanced through the docking element into the duodenum up to theligament of treitz.

FIG. 12 is a drawing showing the endoscope and delivery catheteradvanced through the docking element into the duodenum up to theligament of treitz. The outer sheath of the delivery catheter isretracted to partially expose the tubular implant.

FIG. 13 is a drawing showing the endoscope and delivery catheteradvanced through the docking element into the duodenum up to theligament of treitz. The outer sheath of the delivery catheter isretracted to partially expose the tubular implant. A balloon catheter isinserted through the working channel of the endoscope to the area of thepartially exposed tubular implant. The balloon is inflated totemporarily secure the tubular implant to the duodenum.

FIG. 14 is a continuation of FIG. 13 where the outer sheath is retractedfurther to unsheath the tubular implant up to the duodenal bulb.

FIG. 15 is a continuation of FIG. 14 where the endoscope has beenwithdrawn to the duodenal bulb. The balloon on the balloon catheter isthen deflated and the balloon catheter is withdrawn to the duodenalbulb. The balloon is then re-inflated to open up and secure the proximalend of the tubular implant to the inside diameter of the dockingelement.

FIG. 16 is a drawing of an alternative device and method for deployingthe proximal end of the tubular element.

FIG. 17A is a cross sectional view of a portion of the digestive tractin the body. A docking element is implanted in the esophagus at thegastro-esophageal junction. The docking element serves as an anti-refluxvalve.

FIG. 17B is a cross sectional view of a portion of the digestive tractin the body. A docking element is implanted in the esophagus atgastro-esophageal junction. The docking element serves as a restrictivestoma.

FIG. 18 is a cross sectional view of a portion of the digestive tract inthe body. A docking element is implanted in the esophagus atgastro-esophageal junction. The docking element serves as an anti-refluxvalve.

FIG. 19A is a stented sleeve with a stent used to hold open the sleeve.The sleeve located from the duodenal bulb to the ligament of treitz.

FIG. 19B is a stented sleeve with a stent used to hold open the sleeve.The sleeve located from the pylorus to the ligament of treitz.

FIG. 20 is a stented sleeve with a stent used to hold open the sleeve.The sleeve is located from the stomach antrum to the ligament of treitz.

FIG. 21A is a sectional view of a portion of the digestive tract in thebody. A docking element is implanted in the esophagus at thegastro-esophageal junction. A docking element and tubular implant isimplanted in the duodenum also.

FIG. 21B is a sectional view of a portion of the digestive tract in thebody. A docking element is implanted in the esophagus at thegastro-esophageal junction. A docking element and tubular sleeve isimplanted in the duodenum also. A third implant element bypasses thestomach.

FIG. 22A is a sectional view of a portion of the digestive tract in thebody. A docking element is implanted in the esophagus at thegastro-esophageal junction. A second docking element and tubular implantis implanted from the esophageal implant to the ligament of treitz.

FIG. 22B is a sectional view of a portion of the digestive tract in thebody. A docking element is implanted in the esophagus atgastro-esophageal junction. A docking element and tubular implant isimplanted from the esophageal implant to the duodenal bulb.

FIG. 23A is a sectional view of a portion of the digestive tract in thebody. A docking element and tubular implant is implanted in theesophagus at the gastro-esophageal junction. The modular implant has ananti-reflux valve. A second docking station and tubular implant isplaced in the duodenal bulb and extends to the ligament of treitz. Athird docking station and tubular implant connects the esophagealimplant and the duodenal implant.

FIG. 23B is a sectional view of a portion of the digestive tract in thebody. A docking element and tubular implant is implanted in theesophagus at the gastro-esophageal junction. The modular implant hasan-anti reflux valve. A second docking station and tubular implant isplaced in the pylorus and extends to the ligament of treitz. A thirddocking station and tubular implant connects the esophageal implant andthe duodenal implant at the pylorus.

FIG. 24 is a sectional view of a portion of the digestive tract in thebody. A docking element and tubular implant is implanted in theesophagus at gastro-esophageal junction. The modular implant has an-antireflux valve. A second docking station and tubular implant is placed inthe pyloric antrum and extends to the ligament of treitz. A thirddocking station and tubular implant connects the esophageal implant andthe duodenal implant at the pyloric antrum.

FIG. 25 is a drawing of a delivery catheter with a docking elementloaded onto it.

FIG. 26 is a drawing of a delivery catheter with the endoscope insertedthrough inner diameter of the delivery catheter.

FIG. 27 is a drawing of a delivery catheter which is designed to beinserted through the working channel of the endoscope.

FIG. 28 is a drawing of a delivery catheter with a docking element andtubular implant loaded onto it.

FIGS. 29-35 show a variety of stents that can be used as a dockingelement.

FIG. 36A is a drawing of a stent that can be used as a docking element.

FIG. 36B is a drawing of a stent that can be used as a docking element.

FIGS. 37-39 show docking elements.

FIG. 40A is an expandable ring that can attached to a sleeve to form atubular implant.

FIG. 40B is an expandable ring that can attached to a sleeve to form atubular implant.

FIG. 40C is an expandable ring that can attached to a sleeve to form atubular implant.

FIG. 41 is a tubular implant that uses an expandable ring as in FIG.40A, 40B or 40C as an anchoring means.

FIG. 42 is a tubular implant that uses an expandable ring as in FIG.40A, 40B or 40C as an anchoring means. The tubular implant is placed andsecured within a docking element.

FIG. 43 is a tubular implant that uses an expandable ring as in FIG.40A, 40B or 40C as an anchoring means. The tubular implant is expandedand secured within the docking element.

FIG. 44 is a drawing of a docking element which uses hook and loop tosecure the tubular implant to docking element.

FIG. 45A is a drawing of a tubular implant that has magnets in the wallto allow attachment to another tubular implant or to a docking element.

FIG. 45B is a drawing of a tubular implant that has magnets in the wallto allow attachment to another tubular implant or to a docking element,it has a female receptacle to allow attachment to a docking element orother tubular implant.

FIGS. 46A and 46B show tubular implants.

FIGS. 47A and 47B show tubular implants in which the sleeve haslongitudinal or circumferential pleats, respectively.

FIGS. 48A and 48B show tubular implants or sleeves with a magneticattachment means.

FIG. 49 is a drawing of a tubular implant or sleeve with barbs to attachto attach to tissue or to a docking element.

FIG. 50A is a drawing of a tubular implant or sleeve with pockets toinsert magnets to allow attachment to a docking element or to anothertubular implant.

FIG. 50B is a drawing of a tubular implant or sleeve with hooks toattach docking element or another tubular implant.

FIG. 51A is a conical or tapered shaped docking element or tubularimplant.

FIG. 51B is a docking element or tubular implant with a steppeddiameter.

FIG. 52 is a tubular implant that has hook and loop (velcro) attachmentmeans to attach to a docking element or another tubular implant.

FIG. 53A is an over the wire balloon catheter for delivering andexpanding balloon expandable stents for a docking element.

FIG. 53B is a rapid exchange balloon catheter for delivering andexpanding balloon expandable stents for a docking element.

FIG. 54 shows a docking element design with a single-braided orlaser-cut design placed at the pyloric junction.

FIG. 55 shows another docking element designed where the stomach side ofdocking element is more disk-like.

FIGS. 56 and 57 show docking elements of FIG. 55 and FIG. 56 coveredwith fabric or polymer sheets in areas where they contact tissue.

FIG. 58 shows a different design of the docking element placed withinthe pylorus, where two metallic elements (one on the stomach side andone on the duodenal side) are connected by a flexible sleeve element

FIG. 59 depicts the docking element of FIG. 58 where the flexible sleeveelement has expanded with the opening of the pyloric valve.

FIG. 60 depicts another docking element design incorporating a flexiblesleeve element.

FIG. 61 depicts a tubular implant which can be reversibly attached tovarious compatible docking elements described elsewhere such as thoseshown in FIGS. 54 through FIG. 58.

FIG. 62 shows delivery of the tubular implant of FIG. 61 close to thedocking element of FIG. 54.

FIG. 63 depicts the docking element and the tubular element matedtogether upon release from the delivery catheter

FIG. 64 shows where the tubular element is now attached to the dockingelement of FIG. 58

FIG. 65 shows a situation where the tubular element is attached to thedocking element of FIG. 58 on the stomach portion of the dockingelement.

FIGS. 66-78 show schematic views of various stages of an implantationmethod according to embodiments of the invention.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims

DETAILED DESCRIPTION

FIG. 1 is a schematic, sectional view of an embodiment of the inventionimplanted in a portion of a human digestive tract. As a person ingestsfood, the food enters the mouth 100, is chewed, and then proceeds downthe esophagus 101 to the lower esophageal sphincter at thegastro-esophageal junction 102 and into the stomach 103. The food mixeswith enzymes in the mouth 100 and in the stomach 103. The stomach 103converts the food to a substance called chyme. The chyme enters thepyloric antrum 104 and exits the stomach 103 through the pylorus 106 andpyloric orifice 105. The small intestine is about 21 feet long inadults. The small intestine is comprised of three sections. The duodenum112, jejunum 113 and ileum (not shown). The duodenum 112 is the firstportion of the small intestine and is typically 10-12 inches long. Theduodenum 112 is comprised of four sections: the superior, descending,horizontal and ascending. The duodenum 112 ends at the ligament oftreitz 109. The papilla of vater 108 is the duct that delivers bile andpancreatic enzymes to the duodenum 112. The duodenal bulb 107 is theportion of the duodenum which is closest to the stomach 103.

As shown in FIG. 1, a docking or anchoring element 110 is implanted inthe duodenal bulb 107 and a tubular or therapy implant 111 is attachedto the docking element and extended into the duodenum 112 to theligament of treitz 109. In this embodiment, magnets 135 on the dockingelement 110 and magnets 136 on the tubular implant 111 are magneticallyattracted to each other and thereby secure the docking element 110 tothe therapy implant 111. According to various exemplary embodiments, theanchoring element 110 includes an expandable structure (e.g., a stent orring) adapted for anchoring within the duodenal bulb and has a diameterof between about 20 and about 40 mm in its unrestrained expandedconfiguration. In these embodiments, the magnets 135 on the docking oranchoring element 110 serve as a docking feature for releasably couplingwith the magnets 136 of the tubular implant 111.

FIG. 2 is a schematic view of a portion of the digestive tract in ahuman body. An endoscope 114 has been inserted through the mouth 100,esophagus 101, the gastro-esophageal junction 102 and into the stomach103. The endoscope 114 further extends into the pyloric antrum 104 toallow visualization of the pylorus 106.

FIG. 3 is a drawing of an endoscope 114. Endoscopes 114 are commonlyused for diagnostic and therapeutic procedures in the gastrointestinal(GI) tract. The typical endoscope 114 is steerable by turning two rotarydials 115 to cause deflection of the working end 116 of the endoscope.The working end of the endoscope 116 or distal end, typically containstwo fiber bundles for lighting 117, a fiber bundle for imaging 118(viewing) and a working channel 119. The working channel 119 can also beaccessed on the proximal end of the endoscope. The light fiber bundlesand the image fiber bundles are plugged into a console at the plug inconnector 120. The typical endoscope has a working channel, for example,having a diameter in the 2 to 4 mm diameter range. It may, for examplehaving a working channel having a diameter in the 2.6 to 3.2 mm range.The outside diameter of the endoscopes are typically in the 8 to 12 mmdiameter range depending on whether the endoscope is for diagnostic ortherapeutic purposes.

FIG. 4A is a partial sectional view of an over the wire sizing balloon121 that is used to measure the diameter of the pylorus 106, duodenalbulb 107, esophagus 102, pyloric antrum 104 or other lumen in the GItract. The sizing balloon is composed of the following elements: aproximal hub 122, a catheter shaft 124, a distal balloon component 125,radiopaque marker bands 126, a distal tip 127, a guide wire lumen 128,and an inflation lumen 129. The distal balloon component 125 can bemade, for example, from silicone, silicone polyurethane copolymers,latex, nylon 12, PET (Polyethylene terphalate) Pebax (polyether blockamide), polyurethane, polyethelene, polyester elastomer or othersuitable polymer. The distal balloon component 125 can be molded intoany desired shape, including for example a cylindrical shape, a dog boneshape, or a conical shape. The distal balloon component 125 can be madecompliant or noncompliant. The distal balloon component 125 can bebonded to the catheter shaft 124 with glue, heat bonding, solventbonding, laser welding or any suitable means. The catheter shaft can bemade from silicone, silicone polyurethane copolymers, latex, nylon 12,PET (Polyethylene terphalate) Pebax (polyether block amide),polyurethane, polyethylene, polyester elastomer or other suitablepolymer. Section A-A (shown at the top portion of FIG. 4A) is a crosssection of the catheter shaft 124. The catheter shaft 124 is shown as adual lumen extrusion with a guide wire lumen 128 and an inflation lumen129. The catheter shaft 124 can also be formed from two coaxial singlelumen round tubes in place of the dual lumen tubing. The balloon isinflated by attaching a syringe (not shown) to luer fitting side port130. The sizing balloon accommodates a guidewire through the guidewirelumen from the distal tip 127 through the proximal hub 122. The sizingballoon 121 can be filled with a radiopaque dye to allow visualizationand measurement of the size of the anatomy with a fluoroscope. In theembodiment of FIG. 4A, the sizing balloon 121 has two or more radiopaquemarker bands 126 located on the catheter shaft to allow visualization ofthe catheter shaft and balloon position. The marker bands 126 also serveas fixed known distance reference point that can be measured to providea means to calibrate and determine the balloon diameter with the use ofthe fluoroscope. The marker bands can be made from tantalum, gold,platinum, platinum iridium alloys or other suitable material.

FIG. 4B is a partial sectional view of a rapid exchange sizing balloon134 that is used to measure the diameter of the pylorus 106, duodenalbulb 107, esophagus 102, pyloric antrum 104 or other lumen in the GItract. The sizing balloon is composed of the following elements: aproximal luer 131, a catheter shaft 124, a distal balloon component 125,radiopaque marker bands 126, a distal tip 127, a guide wire lumen 128,and an inflation lumen 129. The materials of construction will besimilar to that of the sizing balloon 121 of FIG. 4A. The guide wirelumen 128 does not travel the full length of the catheter, it starts atthe distal tip 127 and exist out the side of the catheter at distanceshorter that that the shorter that the overall catheter length. A guidewire 132 is inserted into the balloon catheter to illustrate theguidewire path through the sizing balloon 134. As shown in FIG. 4B, thesizing balloon catheter shaft changes section along its length from asingle lumen at section B-B 133 to a dual lumen at section A-A at 124.

FIG. 5 is a schematic view of a portion of the digestive tract in thebody. An endoscope 114 is inserted into the GI tract up to the pylorus106. A sizing balloon 121 is inserted through the working channel 119 ofthe endoscope and into the area of the duodenal bulb 107. The sizingballoon 121 is inflated with contrast agent. The diameter of theduodenal bulb 107 is measured with a fluoroscope.

FIG. 6A shows various views of a stent that can used as a docking oranchoring element. The stents of this invention can be comprised, forexample, of any one or more of the following materials: Nickel titaniumalloys (Nitinol), Stainless steel alloys: 304, 316L, BioDur® 108 Alloy,Pyromet Alloy® CTX-909, Pyromet® Alloy CTX-3, Pyromet® Alloy 31,Pyromet® Alloy CTX-1, 21Cr-6Ni-9Mn Stainless, 21Cr-6Ni-9Mn Stainless,Pyromet Alloy 350, 18Cr-2Ni-12Mn Stainless, Custom 630 (17Cr-4Ni)Stainless, Custom 465® Stainless, Custom 455® Stainless Custom 450®Stainless, Carpenter 13-8 Stainless, Type 440C Stainless, Cobaltchromium alloys- MP35N, Elgiloy, L605, Biodur® Carpenter CCM alloy,Titanium and titanium alloys, Ti-6Al-4V/ELI and Ti-6Al-7Nb, Ti-15MoTantalum, Tungsten and tungsten alloys, Pure Platinum , Platinum-Iridiumalloys, Platinum-Nickel alloys, Niobium, Iridium, Conichrome, Gold andGold alloys. The stent may also be comprised of the following absorbablemetals: Pure Iron and magnesium alloys. The stent may also be comprisedof the following plastics: Polyetheretherketone (PEEK), polycarbonate,polyolefin's, polyethylene's, polyether block amides (PEBAX), nylon 6,6-6, 12, Polypropylene, polyesters, polyurethanes,polytetrafluoroethylene (PTFE) Poly(phenylene sulfide) (PPS),poly(butylene terephthalate) PBT, polysulfone, polyamide, polyimide,poly(pphenylene oxide) PPO, acrylonitrile butadiene styrene (ABS),Polystyrene, Poly(methyl methacrylate) (PMMA), Polyoxymethylene (POM),Ethylene vinyl acetate, Styrene acrylonitrile resin, Polybutylene. Thestent may also be comprised of the following absorbable polymeres: Poly(PGA), Polylactide (PLA), Poly(-caprolactone), Poly(dioxanone)Poly(lactide-coglycolide). Stent 137 stent according to variousembodiments is laser cut from a round tubing or from a flat sheet ofmetal. The flat representation of the stent circumference is shown initem 138. The flat representation of an expanded stent is shown in item139. The end view of the stent is shown 141. Magnets 140 are attached tothe stent on the outside diameter. The magnets may be attached to thestent by use of a mechanical fastener, glue, suture, welding, snap fitor other suitable means. The stent can be either balloon expandable orself expanding. The magnets may be located in middle of the stent or atthe ends of the stent. Suitable materials for the magnets include:neodymium-iron-boron [Nd—Fe—B], samarium-cobalt [Sm—Co], alnico, andhard ferrite [ceramic] or other suitable material. In some embodiments,the magnets are encapsulated in another metal (e.g., titanium) orpolymer to improve corrosion resistance and biocompatibility.

FIG. 6B shows various views of a stent that can used as a docking oranchoring element. Stent 142 may be laser cut from a round tubing orfrom a flat sheet of metal. The flat representation of the stentcircumference is shown in item 143. The flat representation of anexpanded stent is shown in item 144. The end view of the stent is shown145. Permanent magnets 140 are attached to the stent on the outsidediameter. This stent is a covered stent. The stent covering is not shownon items 142, 143 or 144. The covering are shown on the end view whichshows stent 145. Stent may have an outside covering 146, inside covering147 or both. Suitable materials for the covering include but are notlimited to: silicone, polyether block amides (PEBAX), polyurethanes,silicone polyurethane copolymers, nylon 12, polyethylene terphalate(PET), Goretex ePTFE, Kevlar , Spectra, Dyneena, polyvinyl chloride(PVC), polyethylene or polyester elastomers. The coverings may be dipcoated onto the stent or they may be made as a separate tube and thenattached to the stent by adhesives or mechanical fasteners such assuture, rivets or by thermal bonding of the material to the stent oranother layer. The covering may also have drugs incorporated into thepolymer to provide for a therapeutic benefit. The covering 146 or 147may also be of biologic origin. Suitable biologic materials include butare not limited to: Amnion, Collagen Type I, II, III, IV, V, VI—Bovine,porcine, ovine, placental tissue or placental veins or arteries andsmall intestinal sub-mucosa.

FIG. 7 is a tubular therapy implant that can be used to bypass thestomach 103, duodenum 112 or other intestinal lumens (e.g., a portion orall of the jejunum). The tubular implant is made of a thin wall tube 148and a series of magnets 140 attached to the inside of the thin walltube. According to other embodiments, the magnets 140 may be attached tothe outside of the tube 148. According to various embodiments, themagnets 140 are disposed about a circumference of the tube 148 such thatthe location of the magnets correspond to locations of correspondingmagnets located on the anchoring or docking element. The tubularimplants of this invention may be comprised, for example, of thefollowing materials: silicone, polyether block amides (PEBAX),polyurethanes, silicone polyurethane copolymers, Nylon, polyethyleneterphalate (PET), Goretex ePTFE, Kevlar, Spectra, Dyneena, polyvinylchloride (PVC), polyethylene, polyester elastomers or other suitablematerials. The thin wall tube length 149 may range from 1 inch in lengthup to 5 feet in length. The thickness of the thin walled tube willtypically be in the range of 0.0001 inches to 0.10 inches. The diameterof the tubular implant will range from typically 25 to 35 mm, but mayalso range anywhere from 5 mm to 70 mm in diameter.

Exemplary tubular elements for performing intra-luminal gastrointestinaltherapies, e.g., treating metabolic disorders, which may be used withthe system of present invention include, for example, those elementsdisclosed in any of U.S. Pat. Nos. 4,134,405; 4,314,405; 4,315,509;4,641,653; 4,763,653; and 5,306,300, each of which is herebyincorporated by reference in its entirety.

FIG. 8 is a schematic view of a delivery catheter for a delivering aself expanding docking or anchoring element 110 and tubular or therapyimplant 111, according to various embodiments of the invention. Thedelivery catheter is constructed with a central lumen 150 sufficientlylarge to allow the catheter to loaded be over the outside diameter ofthe endoscope 114. The delivery catheter consists of an outer catheter151 and an inner catheter 152. To load the tubular implant onto thedelivery catheter, the outer sheath handle 153 is retracted towards theinner catheter handle 154 until distance 155 (between the outer handle153 and inner handle 154) is relatively small. The tubular implant 111is then compressed around the inner catheter, and the outer sheath ispartially closed by advancing the outer sheath handle 153 away from theinner sheath handle 154. When the tubular implant is completely (orsufficiently) covered by the outer sheath or catheter 151, the loadingprocess is complete for the tubular implant. The delivery catheter alsohas a space on the inner catheter 151 for the docking or anchoringimplant 110 to be loaded. As shown in FIG. 8, the anchoring implant 110is compressed around the distal portion of the inner catheter 152. Theouter sheath handle 153 is then advanced distally until it completely(or sufficiently) covers and retains the anchoring implant. In oneembodiment, the tubular or therapy implant 111 is compressed over theinner catheter and the outer catheter is placed over the outside (leftto right in FIG. 8) of the tubular implant 111.

As further shown in FIG. 8, according to exemplary embodiments, a stentretainer 159 is attached to the inner catheter. The stent retainer 159acts to prevent the stent (e.g., the anchoring or docking implant 110)from releasing from the delivery catheter prematurely during deployment.The stent retainer is fastened to the inner catheter. The stent retainer159 can be made from metal or plastic and can be made radiopaque bymaking from it from a radiopaque material such as tantalum. The stentretainer has a complementary shape that holds the tips on the stent anddoes not allow the stent to move distally or forward until the outersheath 151 is fully retracted to the stent retainer 159.

The catheter has a side port 156 which allows the space between theinner and outer sheaths to be flushed with saline. The outer sheath 151and inner sheath 152 may be made from made from a simple single layerpolymer extrusion such as from polyethylene or PTFE. The outer sheathmay also be constructed in the following manner. The sheath innerdiameter surface is constructed of a thin wall PTFE liner 157. A layerof reinforcement 158 is placed over the PTFE liner, the reinforcement ispreferably either a braid of wire or a coil of wire. The wire crosssection can be either round or rectangular. The preferred material forthe wire is a metal such as 316 or 304 stainless steel or Nitinol orother suitable material. The wire diameters are typically in the 0.0005inch to 0.010 inch diameter range. The outer jacket material ispreferably reflowed into the reinforcement layer by melting the materialand flowing it into the spaces in between the braided wire or the coilwires.

FIGS. 9A-16 shows a series of steps in the implantation of the apparatusherein disclosed, according to an exemplary embodiment. FIG. 9A is aschematic view of a portion of the digestive tract in the body. Adelivery catheter with a docking element 110 and tubular implant 111loaded onto the catheter are loaded over the outside of an endoscope.The endoscope is then advanced through the esophagus, stomach, such thata distal portion is located in the pylorus or the duodenal bulb. FIG. 9Bis a schematic view of a portion of the digestive tract in the body. Asshown, a delivery catheter with a docking element 110 and tubularimplant 111 loaded onto the catheter are loaded onto an endoscope. Theendoscope is then advanced through the esophagus, stomach and into theduodenal bulb. The outer sheath or catheter 151 is then retracted bymoving outer handle 153 towards inner handle 154 to deploy the dockingor anchoring element 110. FIG. 10 is a schematic view of a portion ofthe digestive tract in the body. The drawing shows the docking element110 fully deployed into the duodenal bulb 107. The delivery catheter andendoscope have been has been removed to show clarity.

FIG. 11 is a schematic view showing the delivery catheter (of FIG. 9),wherein the docking element is fully deployed, further advanced into theduodenum 112 until the distal end of the delivery catheter is disposedat or near the ligament of treitz 109. Next, as shown in FIG. 12, theouter sheath 151 of the delivery catheter is refracted slightly (e.g.,1-3 centimeters) to expose the distal portion of the tubular implant111. Also, the tubular implant 111 is advanced forward slightly (e.g.,1-5 centimeters), such that a sufficient amount of the distal end of thetubular implant 111 is disposed beyond the distal most portion of boththe inner sheath 152 and the outer sheath 151. In some embodiments, thisis accomplished by use of a third intermediate sleeve to apply a distalforce to the tubular implant 111. In other embodiments, after deployingthe anchoring element, the physician removes the endoscope from thepatient, loads the tubular implant with a sufficient amount extendingdistally, then advances the endoscope to the appropriate locations anddeploys the tubular implant 111.

Then, in FIG. 13, a sizing balloon 121 has been inserted through theworking channel 119 on endoscope 114. The sizing balloon 121 is advancedslightly (e.g., 1-2 inches) beyond the distal end of the endoscope 114but still inside of the tubular implant 111. The sizing balloon 121 isthen inflated with saline or contrast agent to generate sufficientradial force to hold the tubular implant 111 in place in the duodenum112 near the ligament of treitz 109.

Next, as shown in FIG. 14, the outer sheath 151 is retracted further toexpose much or most (e.g., all but 1-3 centimeters) of the tubularimplant 111. The outer sheath 151 end is now located at or near thepylorus 106. Then, a shown in FIG. 15, the distal end of the endoscope114 has been pulled back to the pyloric orifice 105 and the sizingballoon 121 has been deflated and repositioned at a location near theproximal end of the tubular implant 111. The sizing balloon 121 is thenreinflated to force or urge the proximal end of the tubular implant 111into contact with the docking element 110, such that the magnets 140 onthe tubular sleeve are now in contact with the magnets 140 on thedocking element. The magnetic attraction between the magnets 140 securesthe tubular implant 111 to the docking element 110. The endoscope 114 isthen removed and the procedure is complete.

FIG. 16 shows an alternative embodiment for securing the proximal end ofthe tubular implant 111 to the docking element 110. As shown, accordingto various embodiments, a Nitinol conical and tubular shaped forceps 160are attached to the inner catheter near the proximal end of where thetubal implant is loaded on the delivery catheter. The Nitinol forceps160 are configured to have an elastic memory in the open state. When theouter sheath 151 is full refracted the conical forceps open and in turnurge open the proximal end of the tubular implant 111 to seat themagnets on the tubular implant 111 to the magnets on the docking station110.

At some point during or after implantation of the docking element 110 orthe tubular implant 111, the physician may wish to remove one or bothcomponents. Either or both components may be readily removed using anyof a number of techniques generally known in the art. One such techniquefor removing or extracting the stent or stent-like portion of thedocking element 110 or the tubular implant 111 involves use of aretrieval hook and a collapsing sheath or overtube. One such exemplarysystem is disclosed in EP 1 832 250, which is hereby incorporated byreference in its entirety. Other removal or extraction systems aredisclosed, for example in each of U.S. Publication 2005/0080480, U.S.Pat. No. 5,474,563, and U.S. Pat. No. 5,749,921, each of which is herebyincorporated by reference in its entirety.

FIG. 17A is a schematic view of a portion of the digestive tract in thebody. A docking element 160 is implanted in the esophagus atgastro-esophageal junction 102. The docking element serves as ananti-reflux valve when the tube 161 is compressed flat by pressure inthe stomach 103. FIG. 17B is a schematic view of a portion of thedigestive tract in the body. A docking element 162 is implanted in theesophagus at gastro-esophageal junction 102. The docking element 162 hasa neck or narrow portion having an inside diameter less than thediameter of the native gastro-esophageal junction. Due to this reduceddiameter, the docking element 162 serves as a restrictive stoma. FIG. 18is a schematic view of a portion of the digestive tract in the body. Adocking element 164 is implanted in the esophagus at gastro-esophagealjunction 102. A tubular implant 165 is attached to the docking element164. The tubular implant can have bi-leaflet reflux valve 166, atri-leaflet reflux valve 167, a quad-leaflet reflux valve 168, apenta-leaflet reflux valve 169, a six-leaflet reflux valve 170 orseven-leaflet reflux valve.

FIG. 19A is a schematic view showing an alternative embodiment of theinvention, wherein a docking element is not used but a stented sleeve171 is used. A stent is used to hold open the sleeve and anchor it. Thesleeve extends from a proximal end in or near the duodenal bulb 107 to adistal end at or near the ligament of treitz 109. Those of skill in theart will understand that, in the stented-sleeve construct above, thestent and the sleeve could be mechanically pre-attached, such as bysutures or other chemical and mechanical bonding in which case theexpansion of the stent results in anchoring of the stented sleevestructure on to the tissue. On the other hand, the stent could alsoreside freely within the sleeve at its end and when expanded could pressthe sleeve against the tissue to anchor it. All the stents and deliverycatheters herein disclosed may also be used to deliver and anchor astented sleeve or deliver a stent within a sleeve to anchor it on tosurrounding tissue.

FIG. 19B is an alternative embodiment of the invention wherein a dockingelement is not used but a stented sleeve 172 is used. A stent is used tohold open the sleeve and anchor it. As shown, in this embodiment, thesleeve extends from a proximal end at or near the pylorus 106 to adistal end at or near the ligament of treitz 109. Those of skill in theart will understand that in the stented-sleeve construct above the stentand the sleeve could be mechanically pre-attached, such as by sutures orother chemical and mechanical bonding in which case the expansion of thestent results in anchoring of the stented sleeve structure on to thetissue. On the other hand the stent could also reside freely within thesleeve at its end and when expanded could press the sleeve against thetissue to anchor it. All the stents and delivery catheters hereindisclosed may also be used to deliver and anchor a stented sleeve ordeliver a stent within a sleeve to anchor it on to surrounding tissue.

FIG. 20 is an alternative embodiment of the invention wherein a dockingelement is not used but a stented sleeve 172 is used. A stent is used tohold open the sleeve and anchor it. As shown, in this embodiment, thesleeve extends from a proximal end in the pyloric antrum 104 to a distalend at or near the ligament of treitz 109. Those of skill in the artwill understand that in the stented-sleeve construct above the stent andthe sleeve could be mechanically pre-attached, such as by sutures orother chemical and mechanical bonding in which case the expansion of thestent results in anchoring of the stented sleeve structure on to thetissue. On the other hand the stent could also reside freely within thesleeve at its end and when expanded could press the sleeve against thetissue to anchor it. All of the stents and delivery catheters hereindisclosed may also be used to deliver and anchor a stented sleeve ordeliver a stent within a sleeve to anchor it on to surrounding tissue.

FIG. 21A shows an embodiment of the invention wherein a first docking(or anchoring) element 174 or a stented sleeve is implanted in thegastro-esophageal junction 102 and a second docking (or anchoring)element 175 or stented sleeve is implanted in the duodenal bulb 107.FIG. 21B shows an embodiment of the invention wherein a first dockingelement 174 or a stented sleeve is implanted in the gastro-esophagealjunction 102, a second docking element 175 or stented sleeve in theduodenal bulb 107, and a third docking element and tubular implant 176is implanted to bypass the stomach from 174 to 175.

FIG. 22A is an alternative embodiment of the invention wherein a firstdocking element 178 is implanted in the gastro-esophageal junction 102,a second docking element 177 and tubular implant is implanted extendingfrom the docking element 178 to a distal end at or near the ligament oftreitz. FIG. 22B is an alternative embodiment of the invention wherein afirst docking element 178 is implanted in the gastro-esophageal junction102, a second docking element 179 and tubular implant is implanted fromthe 178 docking element to the duodenal bulb 107.

FIG. 23A is an alternative embodiment of the invention wherein a firstdocking element 180, having an anti-reflux valve, is implanted in thegastro-esophageal junction 102, a second docking element 181 and tubularimplant is implanted from the duodenal bulb 107 to a location at or nearthe ligament of treitz. A third docking element 182 and tubular implantis implanted from the docking element 180 to the docking element 181.FIG. 23B is an alternative embodiment of the invention wherein a firstdocking element 180 with an anti-reflux valve is implanted in thegastro-esophageal junction 102, a second docking element 183 and tubularimplant is implanted from a the pylorus 106 to the ligament of treitz. Athird docking element 184 and tubular implant is implanted from the 183docking to the 184 docking element.

FIG. 24 is an alternative embodiment of the invention wherein a firstdocking element 185 with an anti-reflex valve is implanted in thegastro-esophageal junction 102, a second docking element 186 and tubularimplant is implanted from the pyloric antrum 104 to the ligament oftreitz. A third docking element and tubular implant 187 is implantedfrom the docking element 185 to the docking element 186. As shown, theimplant 187 includes a stent or stent-like anchoring element, which isadapted for delivery in a compressed configuration and to engage thefirst docking element 185 in an expanded configuration.

FIG. 25 is a schematic view of a delivery catheter for a self expandingdocking element 110, according to embodiments of the invention. As shownin FIG. 25, the catheter is preloaded with the docking element but notthe tubular implant. The delivery catheter is constructed with a centrallumen 150 sufficiently large to allow the catheter to loaded be over theoutside diameter of an endoscope. The delivery catheter consists of anouter catheter 151 and an inner catheter 152. To load the tubularimplant onto the delivery catheter the outer sheath handle 153 isretracted towards the inner catheter handle 154 until distance 155 issufficiently small. Once the tubular implant is loaded over the innercatheter, the outer sheath is partially closed by advancing the outersheath handle away from the inner sheath handle 154. The outer sheath151 is then advanced further until the tubular implant is completely (orsufficiently) covered by the outer sheath.

The delivery catheter also has a space on the inner catheter for themodular implant 110 to be loaded. Attached to the inner catheter is astent retainer 159. The purpose of the stent retainer 159 is to preventthe stent from releasing from the delivery catheter prematurely duringdeployment. The stent retainer is fastened to the inner catheter. Thestent retainer 159 can be made from metal or plastic and can be maderadiopaque by making from it from a radiopaque material such astantalum. The stent retainer has a complementary shape that holds thetips on the stent and does not allow the stent to move distally orforward until the outer sheath 151 is fully retracted to the stentretainer 159. The catheter has a side port 156 which allows the spacebetween the inner and outer sheaths to be flushed with saline. The outersheath 151 and inner sheath 152 may be made from made from a simplesingle layer polymer extrusion such as from polyethylene or PTFE. Theouter sheath may also be constructed in the following manner. The sheathinner diameter surface is constructed of a thin wall PTFE liner 157. Alayer of reinforcement 158 is placed over the PTFE liner, thereinforcement is preferably either a braid of wire or a coil of wire.The wire cross section can be either round or rectangular. The preferredmaterial for the wire is a metal such as 316 or 304 stainless steel orNitinol or other suitable material. The wire diameters are typically inthe 0.0005 inch to 0.010 inch diameter range. The outer jacket materialis preferably reflowed into the reinforcement layer by melting thematerial and flowing it into the spaces in between the braided wire orthe coil wires.

FIG. 26 is a schematic view showing the delivery catheter for theapparatus disclosed loaded over an endoscope. FIG. 27 is a schematicview of an alternative delivery catheter for a self expanding dockingelement 110, tubular implant 111 or for both 110 and 111 on the samecatheter. The delivery catheter is constructed with a smaller outsidediameter to allow the catheter to be inserted through the workingchannel of the endoscope 114. The delivery catheter consists of an outercatheter 151 and an inner catheter 152. Attached to the inner catheteris a stent retainer 159. The purpose of the stent retainer 159 is toprevent the stent from releasing from the delivery catheter prematurelyduring deployment. The stent retainer is fastened to the inner catheter.The stent retainer 159 can be made from metal or plastic and can be maderadio-opaque by making from it from a radio-opaque material such astantalum. The stent retainer has a complementary shape that holds thetips on the stent and does not allow the stent to move distally orforward until the outer sheath 151 is fully retracted to the stentretainer 159.

The catheter has a side port 156 which allows the space between theinner and outer sheaths to be flushed with saline. The outer sheath 151and inner sheath 152 may be made from made from a simple single layerpolymer extrusion such as from polyethylene or PTFE. The outer sheathmay also be constructed in the following manner. The sheath innerdiameter surface is constructed of a thin wall PTFE liner 157. A layerof reinforcement 158 is placed over the PTFE liner, the reinforcement ispreferably either a braid of wire or a coil of wire. The wire crosssection can be either round or rectangular. The preferred material forthe wire is a metal such as 316 or 304 stainless steel or Nitinol orother suitable material. The wire diameters are typically in the 0.0005inch to 0.010 inch diameter range. The outer jacket material ispreferably reflowed into the reinforcement layer by melting the materialand flowing it into the spaces in between the braided wire or the coilwires. The outside diameter of this catheter will range typically from 1mm to 4 mm. The catheter can be constructed to be an over the wirecatheter or a rapid exchange catheter. For a rapid exchange design theguidewire will enter the central lumen of the distal end of the catheterand exit at point 188. For an over the wire catheter design theguidewire will enter the central lumen of the distal end of the catheterand exit at point 189.

FIG. 28 is a schematic view of an alternative embodiment drawing of adelivery catheter for a self expanding docking element 110 and tubularimplant 111. As shown in FIG. 28, the tubular implant is located distalto the docking element. The delivery catheter could also be used fordelivery of a stented sleeve construct where the sleeve and stent areintegrated together into one implant. The delivery catheter isconstructed with a central lumen 150 large enough to allow the catheterto loaded be over the outside diameter of the endoscope 114. Thedelivery catheter consists of an outer catheter 151 and an innercatheter 152. To load the tubular implant onto the delivery catheter,the outer sheath handle 153 is retracted towards the inner catheterhandle 154 until distance 155 is a sufficiently small. The outer sheathis then partially closed by advancing the outer sheath handle away fromthe inner sheath handle 154. The outer sheath 151 is then furtheradvanced until the tubular implant is completely (or sufficiently)covered by the outer sheath. The delivery catheter also has a space onthe inner catheter for the modular implant 110 to be loaded. Attached tothe inner catheter is a stent retainer 159. The purpose of the stentretainer 159 is to prevent the stent from releasing from the deliverycatheter prematurely during deployment. The stent retainer is fastenedto the inner catheter. The stent retainer 159 can be made from metal orplastic and can be made radio-opaque by making from it from aradioopaque material such as tantalum. The stent retainer has acomplementary shape that holds the tips on the stent and does not allowthe stent to move distally or forward until the outer sheath 151 isfully retracted to the stent retainer 159.

The catheter has a side port 156 which allows the space between theinner and outer sheaths to be flushed with saline. The outer sheath 151and inner sheath 152 may be made from made from a simple single layerpolymer extrusion such as from polyethylene or PTFE. The outer sheathmay also be constructed in the following manner. The sheath innerdiameter surface is constructed of a thin wall PTFE liner 157. A layerof reinforcement 158 is placed over the PTFE liner, the reinforcement ispreferably either a braid of wire or a coil of wire. The wire crosssection can be either round or rectangular. The preferred material forthe wire is a metal such as 316, 304 stainless steel, Nitinol or othersuitable material. The wire diameters are typically in the 0.0005 inchto 0.010 inch diameter range. The outer jacket material is preferablyreflowed into the reinforcement layer by melting the material andflowing the melted polymer into the spaces in between the braided wireor the coiled wires.

FIG. 29 is a drawing of a stent that can used as a docking element.Stent 137 stent is preferably laser cut from a round metal tubing orfrom a flat sheet of metal. The flat representation of the stentcircumference is shown in item 138. The flat representation of anexpanded stent is shown in item 139. The end view of the stent is shown141. Magnets 140 are attached to the stent on the inside diameter. Themagnets may be attached to the stent by use of a mechanical fastener,glue, suture, welding, snap fit or other suitable means. The stent canbe either balloon expandable or self expanding. The magnets may belocated in middle of the stent or at the ends of the stent. Suitablematerials for the magnets include, for example, neodymium-iron-boron[Nd—Fe—B], samarium-cobalt [Sm—Co], alnico, and hard ferrite [ceramic]or other suitable material. The stent may be balloon expanded or selfexpanding.

FIG. 30 is a drawing of a stent that can be used as a docking oranchoring element 110. The stent can be laser cut from metal tubing orfrom a flat sheet of metal. The stent can also be braided or woven fromround or flat wire. As shown in FIG. 30, the stent has a double-layermesh construction and it can a have separation between the two layers toallow other mechanical elements attached to mating tubular implant tomechanically interlock with the stent without exerting any anchoringforce against the tissue.

In the picture shown, the stent has a narrowed diameter in the midpointof the length this will provide for the stent to anchor more securely inanatomical locations such as the pylorus 106. According to otherembodiments, the stent has a cylindrical or other shape of double layerconstruction like a dumbbell shape. The mesh of the stent may be leftopen or it may be covered with a suitable material previously disclosedin this application. Magnets or other mechanical means for attachment ofa tubular implant may be incorporated as disclosed in this application.The stent may be balloon expanded or self expanding. The mesh of thestent may be left open or it may be covered with a suitable materialpreviously disclosed in this application. While the preferred embodimentof the above stent is a double-layer mesh construction, other single ormulti-layer constructs which create hollow space within the structure topermit interlocking with other tubular implants could also be used. Thespace between the two mesh layers of the stent also help prevent orminimize tissue in-growth reaching the second (i.e., inner) layer of thestent and likewise from reaching an tubular or therapy implant coupledto the inner layer of the stent. Preventing or minimizing such tissuein-growth facilitates safe and easy removal (or replacement) of any suchtubular or therapy implant.

FIG. 31A is a drawing of a stent that can be used as a docking oranchoring element. The stent can be braided from round or flat wire. Asdepicted in FIG. 31A, the stent is in the expanded state. The mesh ofthe stent may be left open or it may be covered with a suitablematerial, as previously disclosed in this application. The stent may beballoon expanded or self expanding. The mesh of the stent may be leftopen or it may be covered with a suitable material previously disclosedin this application. FIG. 31B is a drawing of a stent that can be usedas a docking element. The stent can be braided from round or flat wire.As depicted in FIG. 31B, the stent is in the expanded state. The stentmay include magnets 140 attached to the stent. The magnets may be on theinside diameter, outside diameter, both the inside or outside diameteror incorporated into the wall. The magnets can be used as a means toattach a tubular implant such as 111. The mesh of the stent may be leftopen or it may be covered with a suitable material previously disclosedin this application. The stent may be balloon expanded or selfexpanding. The mesh of the stent may be left open or it may be coveredwith a suitable material, as previously disclosed in this application.

FIG. 32A is a drawing of a stent that can be used as a docking oranchoring element. The stent may be laser cut from round metal tubing orfrom a flat sheet of metal. The central portion of the stents diametermay be set to a smaller diameter to provide increased resistance tostent migration. The stent may be balloon expanded or self expanding.The mesh of the stent may be left open or it may be covered with asuitable material previously disclosed in this application. FIG. 32B isa drawing of a stent that can be used as a docking element. The stentmay be laser cut from round metal tubing or from a flat sheet of metal.The central portion of the stents diameter may be shaped to an hourglass shape to provide increased resistance to stent migration. As shownin FIG. 32B, the stent has hoops 190 at the end of the stent. The hoopsmay be used to interlock with a stent retainer 159 on the inner catheter152 to prevent premature deployment for the sheath is full y retracted.Radiopaque markers 191 can be attached to the end of the stent toincrease the radiopacity of the stent. A metal insert may be pressed orswaged into the hoops 190. The insert may be made from a high atomicdensity material such as tantalum, gold, platinum or iridium. The insertmay take form of a disk or sphere and may be plastically deformed tofill the hoop cavity. The stent may be balloon expanded or selfexpanding. The mesh of the stent may be left open or it may be coveredwith a suitable material previously disclosed in this application.

FIG. 33A is a drawing of a stent that can be used as a docking element.Stent is preferably laser cut from round metal tubing or from a flatsheet of metal. The stent may be balloon expanded or self expanding. Themesh of the stent may be left open or it may be covered with a suitablematerial previously disclosed in this application. FIG. 33B is a drawingof a stent that can be used as a docking element. Stent is preferablylaser cut from round metal tubing or from a flat sheet of metal. Thestent may be balloon expanded or self expanding. The mesh of the stentmay be left open or it may be covered with a suitable materialpreviously disclosed in this application.

FIG. 34A is a drawing of a coil stent that can be used as a dockingelement. Stent is preferably made from round or flat wire. The stent ispreferably self expanding, but may be made to be balloon expandable. Thestent also may be laser cut into a coil from tubing. The preferredmaterial for the stent is Nitinol. The mesh of the stent may be leftopen or it may be covered with a suitable material previously disclosedin this application. The stent has a hoop192 at each end of the coil.The stent can be wound down onto a catheter by inserting a pin into thehoops on each end of the stent and rotating the pins in oppositedirections to cause the stent to wind down onto the catheter. FIG. 34Bis a drawing of a coil stent that can be used as a docking element. Thestent is preferably made from round or flat wire. The stent ispreferably self expanding, but may be made to be balloon expandable. Thestent also may be laser cut into a coil from tubing. The preferredmaterial for the stent is Nitinol. The mesh of the stent may be leftopen or it may be covered with a suitable material previously disclosedin this application. The stent has a hoop192 at each end of the coil.The stent can be wound down onto a catheter by inserting a pin into thehoops on each end of the stent and rotating the pins in oppositedirections to cause the stent to wind down onto the catheter. The stenthas magnets 140 and the coil of the stent. The magnets can be used as anattachment means to a tubular implant.

FIG. 35 is a drawing of a coil stent that can be used as a dockingelement. The stent is preferably made from wire or sheet Nitinol metal.Several stents in series adjacent to each other can be used to form thedocking element.

FIG. 36A is a drawing of a stent that can be used as a docking element.Stent is preferably laser cut from round metal tubing or from a flatsheet of metal. The stent is shaped to a conical shape to provideincreased resistance to stent migration and to more closely fit theanatomy. The stent may be balloon expanded or self expanding. The meshof the stent may be left open or it may be covered with a suitablematerial previously disclosed in this application. FIG. 36B is a drawingof a stent that can be used as a docking element. Stent is preferablylaser cut from round metal tubing or from a flat sheet of metal. Thestent is shaped to a have a stepped diameter to provide increasedresistance to stent migration and to more closely fit the anatomy. Thestent may be balloon expanded or self expanding. The mesh of the stentmay be left open or it may be covered with a suitable materialpreviously disclosed in this application.

FIG. 37 shows schematic views of a docking element. The docking elementis composed of three primary components: A stent 194, a sleeve material193 and magnets 140. The stent can be self expanding or balloonexpandable. The sleeve can be any suitable material, as was previouslydisclosed in this application. The magnets may be attached to the sleeveby adhesive or mechanical fasteners such as rivets, screws, suture ormechanical interlocking.

FIG. 38 shows schematic views of a docking element. The docking elementis composed of four primary components: A stent 194, a sleeve material193, radio-opaque markers 196 and pockets 195. The stent can be selfexpanding or balloon expandable. The sleeve can be made from anysuitable material, as was previously disclosed in this application. Thepockets 195 are like small sleeves that are created in the sleevematerial 194. The pockets 195 may be made by sewing or by the use of amechanical fastener. The pockets 195 form receptacles to hold magnets orother fasteners that will be delivered to the pocket, such that thedocking element may be assembled in-situ. This design allows much largermagnetic or mechanical fastening elements to be incorporated into thedocking element. A guide wire may be inserted into the pockets and themagnets or fasteners can be advanced over the guide wire into the pocketunder endoscopic guidance. The sleeve may have holes 197cut into it toallow some fluid transfer through the docking element if desired.

FIG. 39 is a drawing of a docking element. The docking element iscomposed of four primary components: A stent 194, a sleeve material 193,radio-opaque markers 196 and hooks 198. The stent can be self expandingor balloon expandable. The sleeve can be made from any suitable materialas was previously disclosed in this application. The hooks 198 are madefrom metal or plastic and are attached by adhesive, mechanical means orintegrated into the sleeve material. The hooks serve as a dockingfeature for coupling with a corresponding feature on a tubular implant.The sleeve may have holes 197 in it to allow some fluid transfer throughthe docking element if desired.

FIGS. 40A-40C show expandable rings that can be attached to a sleeve toform a tubular implant 111. The rings can be made of metal or plasticand can be self expanding or balloon expandable. In various embodiments,the rings are made of Nitinol. The expandable rings serve as couplingfeature that operate to releasably couple the tubular implant 111 to adocking feature on the docking or anchoring element 110.

FIG. 41 is a drawing of a tubular implant. The implant is composed ofsleeve material 193, expandable ring 199, and a radiopaque marker 196.The sleeve can be any suitable material as was previously disclosed inthis application and the expandable ring can be of any suitable designas disclosed in FIGS. 40A-40C. Holes 197 can be cut into the sleeve toallow drainage through the sleeve. The expandable ring can be fastenedto the sleeve by mechanical fasteners such as suture, wire, clips, or byadhesive or other suitable means. FIG. 42 is drawing of a tubularimplant with expandable ring 199 and sleeve material 193 placed expandedand anchored to a docking or anchoring element (such as, for example,the anchoring element shown in FIG. 30). FIG. 43 is drawing of a tubularimplant with expandable ring 199 and sleeve material 193 placed expandedand anchored to a docking element. The docking element is a modificationto FIG. 30. The docking element has the two layers of braid or material,but is it cylindrical without the hour glass shape of FIG. 30. In bothFIGS. 42 and 43 the coupling feature of the tubular implant isconfigured to releasably couple to the inner portion of the stent (i.e.,the docking feature) of the docking or anchoring element.

FIG. 44 shows a docking element composed of three primary components: Astent 194, a sleeve material 193 and hook and loop fastener (velcro) 200or 201. The stent can be self expanding or balloon expandable. The hookand loop fastener may be sewn or glued onto the sleeve material. Thetubular implant that fastens to the docking element of this constructionmust have the hook fastener if the docking station has the loop fasteneror vice-versa.

FIG. 45A is a drawing of a tubular implant. The tubular implant isdesigned to attach to another tubular implant or to a docking station bya magnetic attachment means. The tubular implant has magnets 140embedded in the wall. Alternatively, the magnets could be located oneither or both of the inner and outer walls. The magnets provide for anend-to-end connection method between components. FIG. 45B shows atubular implant with a complementary end or female component to matchwith the male component of FIG. 45A.

FIGS. 46A shows a basic sleeve that is to be used as a component of adocking station, tubular implant, or for extending a tubular implant.The sleeve has radio-opaque markers 196 and may have holes in the sleeve197 to allow some fluid flow thru the sleeve if required. FIG. 46B showsa basic sleeve that is to be used as a component of a docking station,tubular implant, or for extending a tubular implant. The sleeve hasmagnetic particles or ferromagnetic material 140 incorporated into thesleeve to allow attachment of the sleeve to a magnetic docking stationor tubular implant.

FIG. 47A shows a basic sleeve that is to be used as a component of adocking station, tubular implant, or for extending a tubular implant.The sleeve has magnetic particles or ferromagnetic material 140incorporated into the sleeve to allow attachment of the sleeve to amagnetic docking station or tubular implant. The sleeve also haslongitudinal pleats 202 in the surface to allow it to collapse indiameter more uniformly and may help to reduce the loaded profile. Thelongitudinal pleats may be over the entire length or only a portion ofthe diameter or length. FIG. 47B shows a basic sleeve that is to be usedas a component of a docking station, tubular implant, or for extending atubular implant. The sleeve also has pleats around the circumference203. The circumferential pleats will allow the tubular implant or sleeveto bend easier without kinking.

FIG. 48A shows a tubular implant designed to attach to another tubularimplant or to a docking station by a magnetic attachment means. Thetubular implant has magnets 140 on the outside diameter. FIG. 48B showsa tubular implant designed to attach to another tubular implant or to adocking station by a magnetic attachment means. The tubular implant hasmagnets 140 in the wall thickness.

FIG. 49 shows a tubular implant that is constructed with a sleeve 193material, and set of barbed hooks 204. Hook 204 has 2 barbs per hook,hook 205 has one barb per hook, hook 206 has no barbs, hook 207 and 208have different bend angles. The modular implant can attach to a dockingelement or directly to the anatomy or to another sleeve.

FIG. 50A shows a basic sleeve with pockets 195. The basic sleeve may beused as part of a docking station or tubular implant. FIG. 50B shows abasic sleeve with hooks 198. The sleeve may be used as part of a dockingstation or tubular implant. FIG. 51A is a basic sleeve with a conicaldiameter. The sleeve may be used as part of a docking station or tubularimplant. FIG. 51B is a basic sleeve with a stepped diameter. The simplesleeve may be used as part of a docking station or tubular implant. FIG.52 is a basic sleeve with hook and loop fastener (Velcro) on the outsidediameter. The sleeve may be used as part of a docking station or tubularimplant.

FIG. 53A is a balloon catheter for delivery of stents for dockingelements or stented sleeves. The catheter is an over the wire design.FIG. 53B is a balloon catheter for delivery of stents for dockingelements or stented sleeves. The catheter is of rapid exchange design.

FIG. 54 shows an enlarged view of the gastro-intestinal anatomy of thejunction between the stomach and the duodenum, including the pyloricantrum 104, the pylorus 106, and the duodenal bulb 107. A soft, braideddocking or anchoring element 209 is placed at the pyloric junction(i.e., extending across the pylorus). As shown in FIG. 54, the dockingelement is a variant of the element shown in FIG. 42 using a singlebraid. As shown, the docking element 209 is shaped such that it does notexert radial forces on the stomach wall or the duodenal wall foranchoring. It is retained within the pyloric junction due to its shape,which has an outer diameter larger than the maximum outer diameter ofthe pyloric orifice. As shown in FIG. 54, the docking element 209includes a proximal portion (i.e., the portion located in the pyloricantrum 106), a distal portion (i.e., the portion located in the duodenalbulb 107, and a neck portion adapted to extend through the pylorus 106.According to various embodiments, the proximal and distal portion areshaped such that each has an unconstrained diameter of between about 15and about 25 millimeters, and the neck portion has an unconstraineddiameter of between about 5 and about 15 millimeters. In someembodiments, the ratio of the diameter of the proximal portion to thediameter of the neck portion is between about 1.2 and about 5. Accordingto various embodiments, the neck portion is formed with an unconstraineddiameter smaller than a maximum diameter of the native pylorus, suchthat the neck portion operates to restrict flow from the stomach intothe duodenum (i.e., to function as a restrictive stoma). In otherembodiments, the neck portion is formed with an unconstrained diameterlarger than a maximum diameter of the native pylorus, such that the neckportion does not restrict flow from the stomach into the duodenum (i.e.,through the pylorus).

FIG. 55 shows another docking or anchoring element 210 having analternate shape. In this instance, the proximal portion of the anchoringelement 210 (i.e., the portion located on the pyloric antrum side) ismore disk-like and serve as a pronounced anchoring/retaining flange forthe device. In some embodiments, the anchoring element 210 has a maximumor unconstrained diameter slightly larger than an internal diameter ofthe pyloric antrum, such that the docking element 210 exerts a slightradial force on the wall of the pyloric antrum. In other embodiments,the unconstrained shape is such that the anchoring element 210 does notexert a radial force on the wall of the pyloric antrum. To minimize orprevent abrasive injury to tissue and tissue in-growth, and to providefor ease of replacement exemplary embodiments of the docking elements209 and 210 could be covered with flexible woven fabric or nonwoven,extruded polymeric material used in synthetic medical grafts such aspolyurethane, silicone, ePTFE, etc. FIGS. 56 and 57 show exemplarycovered embodiments where the docking element includes a covering 211.

According to various embodiments, one or both of the proximal portionand the distal portion of the anchoring element are sized or shaped suchthat at least a portion of the anchoring element has an unconstraineddiameter larger than the diameter of the corresponding anatomical organ(e.g., the pyloric antrum or the duodenal bulb), such that whenimplanted the anchoring element exerts a radial force upon the wall ofthe organ.

FIG. 58 shows a different design of the docking element, where thedocking element 213 now consists of separate proximal (i.e., stomachside) and distal (i.e., duodenal side) metallic braided elementsconnected by a flexible sleeve (tubular) element 212. The flexibleelement 212 could be constructed of materials such as silicone,polyurethane, ePTFE, etc., which are resistant to stomach acid, enzymesand intestinal juices. The flexible element 212 is provides minimalinterference to the opening and closing of the pyloric valve. FIG. 58depicts the sleeve element in a somewhat compressed state (hence thedrawing showing wrinkles to the sleeve 212. FIG. 59 depicts the samedocking element 213 where the pylorus 106 is now fully open and thesleeve element 212 is an expanded state. FIG. 60 depicts another dockingelement 214 where the flexible sleeve element 212 is attached to otherdocking structures such as the docking element 210 shown in FIG. 55.According to various embodiments, the flexible element 212 has an outerdiameter substantially similar to the maximum diameter of the nativepylorus. The flexible element 212, for example, may have a diameter ofbetween about 5 and about 15 millimeters. According to otherembodiments, the diameter of the flexible element 212 is set somewhatsmaller than the maximum diameter of the pylorus, such that the flexibleelement 212 acts to restrict flow from the stomach into the duodenum.According to various embodiments, the neck portion is attached to theproximal and distal stent portions by a sewing technique.

FIG. 61 depicts a tubular implant 215, which is a variant of the tubularimplant of FIG. 41. Here, the flexible sleeve portion is more stepped inshape, such as is shown in the tubular implant in FIG. 51B. The steppedportion of the tubular implant can serve the purpose of acting like arestrictive element for food passage, depending on the choice ofdimensions of the inlet and outlet. The tubular element also hasring-like anchoring or coupling features 199 attached to its proximalend similar to the tubular element of FIG. 41.

FIG. 62 depicts the ring like anchoring elements 199 of the tubularimplant 215 of FIG. 61 constrained in a delivery catheter 216 as it isbeing withdrawn close to the docking element. FIG. 63 depicts thedocking element and the tubular implant 215 mated together upon releasefrom the delivery catheter. By withdrawing the delivery catheter whilethe tubular element is anchored in place, the ring like anchoringelements are released from the delivery catheter and expand to theirunconstrained set shape and diameter. Upon such expansion, the fingersor protrusions of the coupling feature 199 engage the distal portion ofthe docking element. In these embodiments, the distal portion of thedocking element is sized and shaped such that the protrusion of thecoupling feature may extend through the openings (i.e., dockingfeatures) in the proximal portion, such that the coupling feature 199 ofthe tubular implant engages the docking or anchoring element. Inaddition to providing an anchoring function by resisting forces directedtoward the pylorus or stomach, the distal portion of the docking element209 further provides some amount of structural support to the tubularimplant 215, which help resist kinking, binding or twisting of thetubular implant.

FIG. 64 shows the tubular implant 215 attached to the docking element213 using the same steps as outlined in FIGS. 62 and 63. FIG. 65 shows avariant of the same concept where the tubular element 215 is nowattached to the stomach side of the docking element 213. Here, thedelivery catheter will have to withdrawn through the pylorus beforeactivating the release of the ring element.

While each of FIGS. 63-65 show a modular system in which a tubularimplant is removably or releasably coupled with a docking or anchoringelement, according to other embodiments, the tubular implant isstructurally integrated with the docking or anchoring element (e.g.,such as is shown in FIGS. 19-20). The tubular implant and dockingelement may be integrated using a variety of techniques, including forexample adhesive bonding, mechanical fastening, sewing, and overmolding.Likewise, according to some embodiments, portions of the system aremodular while other portions are integrally formed. For example,according to exemplary embodiments, the anchoring element and tubularimplant located within the duodenum are integrally formed and thedocking element and tubular implant located at the gastro-esophagealjunction and within the stomach are modular.

FIGS. 66-78 show schematic views of various stages of an implantationmethod according to embodiments of the invention. FIG. 66 shows theinitial stage of a minimally invasive method of implanting any of thevarious embodiments disclosed herein. As shown, the physician hasadvanced (e.g., endoscopically) a delivery system 300 to the pyloricantrum 104. The delivery system 300, according to some embodiments,includes an endoscope for visualization and a dual catheter system forsecuring the prostheses in a collapsed configuration. According to someembodiments, the delivery system 300 includes each of the componentsshown in and described with reference to FIG. 8.

As shown in FIG. 67, the physician has successfully guided the deliverysystem 300 through the pylorus 106, such that a tip of the deliverysystem is located within the duodenal bulb 107. Next, as shown in FIG.68, the physician has actuated the delivery system 300 (e.g, byretracting an outer sheath or catheter), so as to release a distalportion of the docking or anchoring element 110 in the duodenal bulb. Asshown, the physician advances the delivery system 300 a sufficientdistance to allow the distal portion to fully expand within the duodenalbulb 107 and a neck portion of the anchoring element 110 to expandwithin the opening of the pylorus 106. Then, as shown in FIG. 69, thedelivery system 300 is further actuated to effect release of a proximalportion of the anchoring element 110 with the pyloric antrum 104. Asshown, at this stage, the anchoring element 110 is fully disengaged fromthe delivery system. As shown in FIG. 70, the anchoring element isimplanted across the pylorus 106, such that the proximal portion of theanchoring element engages the proximal surface of the pylorus and thedistal portion engages the distal surface of the pylorus.

Next, as shown in FIG. 71, the delivery system 300, which holds thetubular or therapy element 111 in a collapsed configuration, is advancedacross the pylorus 106 into the duodenal bulb 107. The delivery system300, as shown in FIG. 72, is then advanced further down the duodenum(and, as desired, the jejunum), until the tip reaches the desired distalmost implant location. Then, as shown in FIG. 73, the physician actuatesthe delivery system 300 (e.g., by retracting an outer catheter), torelease a distal portion of the therapy element 111 with the duodenum(or jejunum). Next, as shown in FIGS. 74-76, the delivery system isfurther retracted such that the therapy element 111 is further releasedfrom the delivery system 300. As shown in FIGS. 77-78, the therapyelement 111 is fully released from the delivery system 300 and hasengaged the docking element 110.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof

1. A modular system for treating metabolic disorders such as diabetesand obesity, the system comprising: an anchoring element including anexpandable structure configured for engaging at least one of anesophagus, a stomach, a pylorus, and a duodenal bulb, the anchoringelement having a docking feature; and a tubular implant adapted forplacement within the gastro-intestinal tract, the tubular implant havinga coupling feature for engaging and coupling with the docking feature ofthe anchoring element; wherein the docking feature and coupling featureare configured such that the tubular implant is releasably coupled tothe anchoring element to facilitate removal of the tubular implant. 2.The modular system of claim 1 wherein the anchoring element furtherincludes a sleeve element covering a part or an entire surface of thestent.
 3. The modular system of claim 1 wherein the docking element isfabric or elastomeric cuff.
 4. The modular system of claim 1 wherein thedocking feature of the anchoring element comprises a plurality ofmagnetic elements.
 5. The modular system of claim 1 wherein the dockingfeature of the anchoring element comprises a plurality of hook or aplurality of loop fastener elements.
 6. The modular system of claim 1wherein the docking feature of the anchoring element comprises at leastone mechanical element adapted to interlock with a correspondingmechanical element of the coupling feature.
 7. The modular system ofclaim 1 wherein the stent comprises a double-braid stent with a spacebetween an outer braid and an inner braid and further wherein the innerbraid is configured as the docking feature.
 8. The modular system ofclaim 1 wherein the tubular implant comprises at least one tubularelement adapted to function as a conduit for food and organ secretions.9. The modular system of claim 8 wherein the tubular element includes arestrictive feature for restricting the flow of food.
 10. The modularsystem of claim 8 wherein the tubular element includes an anti-refluxvalve.
 11. The modular system of claim 4 wherein the magnetic elementsprovide attachment by either attraction, repulsion or magneticlevitation type mechanisms
 12. A modular system for treating metabolicdisorders such as diabetes and obesity, the system comprising: ananchoring element including an expandable structure configured forengaging at least one body organ selected from the group consisting ofan esophagus, a stomach, a pylorus, and a duodenal bulb, the anchoringelement having a docking feature; and a tubular implant adapted forplacement within the gastro-intestinal tract, the tubular implant havinga coupling feature for releasably coupling with the docking feature ofthe anchoring element; wherein the docking feature and coupling featureare configured such that the tubular implant is releasably coupled tothe anchoring element to facilitate removal of the tubular implant; andwherein the anchoring element is configured such that the dockingfeature is spaced from an internal surface of the body organ.
 13. Themodular system of claim 12 wherein the anchoring element furtherincludes a sleeve element covering a part or an entire surface of thestent.
 14. The modular system of claim 12 wherein the docking feature ofthe anchoring element comprises a plurality of magnetic elements. 15.The modular system of claim 12 wherein the docking feature of theanchoring element comprises at least one mechanical element adapted tointerlock with a corresponding mechanical element of the couplingfeature.
 16. The modular system of claim 12 wherein the stent comprisesa double-braid with a space between an outer braid and an inner braidand further wherein the inner braid is configured as the dockingfeature.
 17. The modular system of claim 12 wherein the tubular implantcomprises a tubular elements adapted to function as conduits for foodand organ secretions.
 18. The modular system of claim 17 wherein thetubular element includes a restrictive feature for restricting the flowof food.
 19. The modular system of claim 17 wherein the tubular elementincludes an anti-reflux valve.
 20. A modular system for treatingmetabolic disorders such as diabetes and obesity, the system comprising:a plurality of anchoring elements for engaging a plurality of bodyorgans selected from the group consisting of an esophagus, a stomach, apylorus, and a duodenal bulb, each of the plurality of anchoring elementhaving a docking feature; a first tubular implant adapted for placementwithin the duodenum, the tubular implant having a coupling feature forengaging and coupling with the docking feature of one of the pluralityof anchoring elements; and a second tubular implant adapted forplacement within the stomach, the second implant having a lengthsufficient to extend from a distal end of the esophagus to a pylorus,the second tubular implant having a coupling feature for coupling withthe docking feature of one of the plurality of anchoring elements;wherein the docking feature and coupling feature are configured suchthat the tubular implant is releasably coupled to the anchoring elementto facilitate removal of the tubular implant.